H. Lundbeck A/S — Brintellix EMA EPAR public assessment report (EMEA/H/C/002717, 2013)
H. Lundbeck A/S · 2013 · EMA EPAR public assessment report · company profile →
Report summary
This EMA assessment report details the regulatory approval of H. Lundbeck A/S's Brintellix (vortioxetine) for Major Depressive Disorder (MDD). It covers the drug's pharmaceutical development, non-clinical safety (including animal toxicities and environmental concerns), and pharmacokinetics, noting CYP enzyme metabolism and drug interactions. Clinical efficacy was demonstrated in short-term and relapse prevention trials, showing superiority over placebo and some comparators, particularly at higher doses, with improvements in MADRS scores and cognitive function. Common adverse events included nausea and headache, with higher incidences in specific populations. The report concludes with a positive benefit-risk balance, outlining safety concerns and the risk management plan.
Key findings — cited to the page
| Incidence of irritability AEs for Vortioxetine (updated MDD short-term pool) | 1.1% % | · p.136 |
| Incidence of irritability AEs for placebo (updated MDD short-term pool) | 1.5% % | · p.136 |
| NOEC Daphnia sp. Reproduction Test | 4.02 µg/L | · p.28 |
| EC10 Collembola, Reproduction Test | 28.7 mg/kg | · p.28 |
| Marketing Authorisation Application submission date | 24 August 2012 | Brintellix · Europe · p.6 |
| CHMP positive opinion date | 21-24 October 2013 | Brintellix · Europe · p.8 |
| Recommended treatment duration after symptom resolution | 6 months | · p.9 |
| Indication applied for | Treatment of major depressive episodes in adults | Brintellix · Europe · p.6 |
| Vortioxetine proposed maximum daily dose | 20 mg | · p.9 |
| Tangible cost of depression | 113 billion euro | Europe · p.8 |
| US Marketing Authorisation date | 30th September 2013 | Brintellix · USA · p.6 |
| Incidence of constipation in patients aged <65 years in Vortioxetine 20 mg group | 4 % | · p.156 |
Source: H. Lundbeck A/S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →